PEA and Scutellaria combined with exercise for chemotherapy-related nerve pain
Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
University of Palermo · NCT07352514
This trial will see if taking PEA and Scutellaria together with therapeutic exercise helps adults who have nerve pain after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Palermo (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Palermo, Italia) |
| Trial ID | NCT07352514 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort in which adults with chemotherapy-induced peripheral neuropathy will be enrolled and followed while receiving post-market nutraceuticals and supervised exercise. Participants will be grouped to compare those receiving PEA plus Scutellaria with standardized therapeutic exercise against other treatment approaches. Outcomes will include patient-reported neuropathic pain severity and measures of nerve health over the follow-up period. The study uses a standardized exercise protocol (EXCAP) and requires a minimum opioid washout to limit confounding from opioid pain control.
Who should consider this trial
Good fit: Adults 18 and older who developed neuropathic pain (NRS ≥ 5) after chemotherapy within the prior six months and who can follow the EXCAP exercise program may be eligible.
Not a fit: People with diabetic neuropathy, severe liver impairment, hypersensitivity to PEA, or severe disabilities preventing exercise are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined nutraceutical and exercise approach could reduce neuropathic pain and improve nerve function and quality of life for people with CIPN.
How similar studies have performed: Smaller studies and case reports have suggested PEA can help neuropathic pain, but combining PEA and Scutellaria with structured exercise is relatively novel and not well established in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older. * Patients who have undergone chemotherapy treatment within the previous 6 months. * Patients treated with PEA, Scutellaria, and standardized therapeutic exercise according to the EXCAP protocol from April 2025 to September 2025. * Patients with a washout period from opioid-based analgesic therapy of at least 10 days or who are not receiving opioid-based analgesic therapy. * Patients presenting with neuropathic pain (NRS ≥ 5). * Patients able to provide written informed consent. Exclusion Criteria: * Patients younger than 18 years. * Patients with hypersensitivity to PEA or any of the excipients listed in the Summary of Product Characteristics (SPC). * Patients with diabetic pathology. * Patients with severe hepatic impairment. * Patients with severe disabilities that compromise the execution of therapeutic exercise.
Where this trial is running
Palermo, Italia
- A.O.U.P. P. Giaccone, Palermo, Italia 90127 — Palermo, Italia, Italy (RECRUITING)
Study contacts
- Study coordinator: Giulia Letizia Mauro
- Email: giulia.letiziamauro@unipa.it
- Phone: +39 0916554160 +39 09165541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain, Chemotherapy-Induced Peripheral Neuropathy, Nutraceuticals, Palmitoylethanolamide, Scutellaria, Therapeutic Exercise, Cancer Patients